Master's Course "Drug Regulatory Affairs"

Study Modules

Modul 03 (WS 2017 / SS 2018)

International Marketing Authorisation Procedures

attendance approx. Seminar Paper Method of examination Credit
approx. 45 h approx. 30 h seminar paper and written examination 7

Module Supervisor

  • Dr. Ekkehard Baader, Basel

Topics

1  

European Union (EU)

   

a) Legal basis and key players

    b) Special Topic - Scientific Advice 
   

c) Mutual Recognition Procedure
    - MRP / Decentralised Procedure
    - MRP: Generics

    d) Special topic - Similar Biological Medicinal Products 
    e) Centralised Procedure
   

f) Special Topics - Community Referrals, Exc. Circumstances, Conditional MA, Acc. Assessment

     
2  

International Markets, Japan, Orphan Medicinal Products, Paediatrics, Drug Counterfeiting

     
3  

United States of America

Study plan

Part 1:    
Friday   27 October 2017 from 8.30 a.m. - 6.30 p.m.
Saturday   28 October 2017 from 8.00 a.m. - 4.00 p.m.
Location:    Haus der evang. Kirche, Adenauerallee 37, Bonn
Part 2:    
Friday   24 November 2017 from 8.30 a.m. - 6.30 p.m.
Saturday   25 November 2017 from 8.00 a.m. - 4.00 p.m.
Location:    Uni-Club
Part 3:    
Friday   08 December 2017 from 8.30 a.m. - 6.30 p.m.
Saturday   09 December 2017 from 8.00 a.m. - 4.00 p.m.
Location:    BfArM, Kurt-Georg-Kiesinger Allee 3, Bonn
     
    Deadline seminar paper: 08 January 2018

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